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Egg Yolk and Underlying Metabolisms on Modifying HDL Levels in Individuals With Metabolic Syndrome

7. april 2022 oppdatert av: Mahidol University

Egg Yolk and Underlying Metabolisms on Modifying HDL Levels and Associated Genetics in Individuals With Metabolic Syndrome

This research compare the effects of low carbohydrate intake and consumption of 3 eggs per day, and low energy diet on diabetes control and biomarkers of CVD in obese people.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This research study examines the effects of changes in weight, metabolism of glucose and cholesterol in the blood through diet and behavior modification. The main objective of this study was to compare the effects of low carbohydrate intake and consumption of 3 eggs per day, and low energy diet on diabetes control and biomarkers of CVD in obese people. In addition, HDL quantity and size as well as HDL function was compared between the group who ate the whole egg and the group who did not eat the yolk.

Studietype

Intervensjonell

Registrering (Faktiske)

76

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Thailand
    • Bangkok
      • Bangkok Noi, Bangkok, Thailand, 10700
        • Faculty of Medicine Siriraj Hospital, Mahidol University

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 60 år (Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. weight stable > 3 months (changing < 5%)
  2. three or more of the following five criteria are met 2.1 waist circumference ≥ 90 cm (men) or ≥ 80 cm (women) 2.2 fasting blood sugar ≥ 100 mg/dl 2.3 fasting triglyceride (TG) level ≥ 150 mg/dl 2.4 fasting high-density lipoprotein (HDL) cholesterol level ≤ 40 mg/dl (men) or ≤ 50 mg/dl (women) 2.5 blood pressure over 130/85 mmHg
  3. can consume food that provided in project
  4. healthy

Exclusion Criteria:

  1. consume drugs i.e. weight loss drugs, herbal pills, asthma drugs, steroid drugs, thyroid drugs, insulin injections, SGLT1 inhibitors drugs, SGLT2 inhibitors drugs, sulfonylurea drugs, blood lipid-lowering drugs
  2. people who exercise vigorously (> 150 minutes per week)
  3. people who are or have weight loss by consuming less than 30% of carbohydrates, or are losing weight by other methods or who have eaten a specific diet as prescribed by a doctor within the past 6 months
  4. people who drink alcohol more than once a week
  5. people who had a LDL level within 6 months > 190 mg/dl
  6. fasting blood glucose levels > 250 mg/dl and using diabetes drugs other than metformin
  7. people with heart disease, type 1 diabetes, renal impairment > level 3A
  8. history of cancer, lung disease, gastrointestinal disease
  9. people who smoke, people with eating disorder, people who have received psychiatric drugs
  10. become a volunteer in a research project that is conducting a study related to food consumption
  11. people who are unable to keep up with the treatment or are expected to be absent in this area for the next 4 months
  12. pregnancy or breastfeeding
  13. egg allergy

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Yolk ketogenic diet
consume carbohydrate < 10% and 3 whole eggs supplement per day in 12 weeks
Atferdsmessig: Diet intervention
Volunteers will be instructed on dietary recommendation throughout the research program to achieve a stable daily energy intake.
Eksperimentell: White ketogenic diet
consume carbohydrate < 10% and 6 white eggs supplement per day in 12 weeks
Atferdsmessig: Diet intervention
Volunteers will be instructed on dietary recommendation throughout the research program to achieve a stable daily energy intake.
Aktiv komparator: Control group
decrease consumption of diet from typical (decreased energy 20%) but consume carbohydrate in normal level
Atferdsmessig: Diet intervention
Volunteers will be instructed on dietary recommendation throughout the research program to achieve a stable daily energy intake.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Changes in weight following dietary intervention
Tidsramme: Baseline and after 12 weeks
weight (kg) analysis
Baseline and after 12 weeks
Changes in body mass index following dietary intervention
Tidsramme: Baseline and after 12 weeks
body mass index (kg/m^2) analysis
Baseline and after 12 weeks
Changes in waist circumference following dietary intervention
Tidsramme: Baseline and after 12 weeks
waist circumference (cm) analysis
Baseline and after 12 weeks
Changes in lipid profiles concentration following dietary intervention
Tidsramme: Baseline and after 12 weeks
Triglycerides (mg/dl), Cholesterol (mg/dl), HDL-cholesterol (mg/dl) and LDL-cholesterol (mg/dl) concentration analysis
Baseline and after 12 weeks
Changes in blood glucose and insulin concentration following dietary intervention
Tidsramme: Baseline and after 12 weeks
HbA1C (%), glucose (mg/dl) and insulin (mg/dl) concentration analysis
Baseline and after 12 weeks
Changes in betahydroxybutirate concentration following dietary intervention
Tidsramme: Baseline and after 12 weeks
betahydroxybutirate (mmol/L) concentration analysis
Baseline and after 12 weeks
Changes in electrolytes concentration following dietary intervention
Tidsramme: Baseline and after 12 weeks
Na+ (mg/dl), K+ (mg/dl), Cl- (mg/dl) and HCO3- (mg/dl) concentration analysis
Baseline and after 12 weeks
Changes in physical activity
Tidsramme: Baseline and after 12 weeks
physical activity (MET-minutes/week) collect data by using questionnaires
Baseline and after 12 weeks
Change from baseline Glycemia at 180 minutes
Tidsramme: Minutes after intake of 75 g glucose: 0, 30, 60, 90, 120, 180
glucose (mg/dl)
Minutes after intake of 75 g glucose: 0, 30, 60, 90, 120, 180
Change from baseline Insulin at 180 minutes
Tidsramme: Minutes after intake of 75 g glucose: 0, 30, 60, 90, 120, 180
insulin (μU/ml)
Minutes after intake of 75 g glucose: 0, 30, 60, 90, 120, 180

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Changes in blood pressure
Tidsramme: Baseline and after 12 weeks
systolic and diastolic blood pressure (mmHg)
Baseline and after 12 weeks
Changes in fasting leptin levels
Tidsramme: Baseline and after 12 weeks
leptin (mg/dl) concentration analysis
Baseline and after 12 weeks
Changes in energy intake following dietary intervention
Tidsramme: Baseline and after 12 weeks
energy (kcal)
Baseline and after 12 weeks
Changes in carbohydrate following dietary intervention
Tidsramme: Baseline and after 12 weeks
carbohydrate (g)
Baseline and after 12 weeks
Changes in protein intake following dietary intervention
Tidsramme: Baseline and after 12 weeks
protein (g)
Baseline and after 12 weeks
Changes in fat intake following dietary intervention
Tidsramme: Baseline and after 12 weeks
fat (g)
Baseline and after 12 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Mahidol University

Samarbeidspartnere

National Research Council of Thailand

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

21. september 2020

Primær fullføring (Faktiske)

31. mai 2021

Studiet fullført (Faktiske)

31. desember 2021

Datoer for studieregistrering

Først innsendt

21. september 2020

Først innsendt som oppfylte QC-kriteriene

28. oktober 2020

Først lagt ut (Faktiske)

29. oktober 2020

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. april 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. april 2022

Sist bekreftet

1. april 2022

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • MU-CIRB 2019/255.0310

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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